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Carvedilol

Phase 4

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Carvedilol development status

Highest phase Phase 4 run by The Alfred (NCT00384566)
Phase scored for VTRSPhase 1
Registered trials 13 across 10 sponsors since May 2003

Carvedilol target and mechanism

Molecular targetADRA1A, ADRA1D, ADRA1B, ADRB1, ADRB2, ADRB3
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL723

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment100

FDA Designations

No designations recorded

Carvedilol clinical trials

Carvedilol · 2 trials · 1 indication

Phase 1 2
NCT00648622Fed Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mgHealthy
COMPLETED50 Analytics
NCT00650416Fasting Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mgHealthy
COMPLETED50 Analytics
PHASE1COMPLETED
Fed Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCarvedilol Tablets 12.5 mg
2ACTIVE_COMPARATORCoreg® Tablets 12.5 mg

Interventions

NameTypeDescription
Carvedilol Tablets 12.5 mgDRUG12.5mg, single dose fed
Coreg® Tablets 12.5 mgDRUG12.5mg, single dose fed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ev...

Countries:United States
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Frequently asked questions about Carvedilol

What is Carvedilol?

Carvedilol is a small molecule drug candidate developed by Viatris Inc. (ticker: VTRS). It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is undisclosed, and the therapeutic area is classified as Other.

What does Carvedilol target?

Carvedilol targets the alpha-1 adrenergic receptors ADRA1A, ADRA1B, and ADRA1D, as well as the beta-adrenergic receptors ADRB1, ADRB2, and ADRB3. It acts as an antagonist at these targets, meaning it blocks receptor activity.

Who makes Carvedilol?

Carvedilol is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the sponsor responsible for the clinical development of this asset.

What phase is Carvedilol in?

Carvedilol is in Phase 1 clinical development. It is an investigational drug candidate and has not been approved by the FDA for the undisclosed indication being studied. Two Phase 1 trials have been completed, and no active trials are currently listed.

What clinical trials is Carvedilol in?

Carvedilol has been evaluated in two completed Phase 1 trials: NCT00650416, a fasting study comparing Carvedilol Tablets 12.5 mg to Coreg Tablets 12.5 mg, and NCT00648622, a fed study with the same comparison. Both enrolled 50 healthy volunteers in the United States.